Endopath
FDA 510(k) K942450 · Ethicon Endo-Surgery, Inc.
510(k) numberK942450
Submission
- Device name
- Endopath
- Applicant
- Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US - Received
- May 23, 1994
- Decision date
- August 5, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GBZ – Catheter, Cholangiography
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973621 | Pre-View Cholangiography ClampGBZ · Traditional | Nashville Surgical Instruments | 12/17/1997SE |
| K944790 | Flexible Laparoscopic Cholangiography CatheterGBZ · Traditional | Applied Medical Resources | 11/29/1994SE |
| K932228 | Microvasive Insurg Chloangiographic CatheterGBZ · Traditional | Boston Scientific Corp | 08/10/1993SE |
| K926217 | Terumo Angiographic Catheter for Laporoscopic UseGBZ · Traditional | Terumo Medical Corp. | 07/13/1993SE |
| K926143 | Angiolapcath Cholangiography KitGBZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/07/1993SESK |
| K924212 | Stryker Endoscopy Cholangiogram KitGBZ · Traditional | Stryker Corp. | 07/07/1993SESK |
| K925742 | Clarus Cholangiogram Catheter KitGBZ · Traditional | Clarus Medical Systems, Inc. | 06/01/1993SESK |
| K924981 | Operative Cholangiogram CatheterGBZ · Traditional | Taut, Inc. | 04/06/1993SE |
| K924480 | Cholangiography ClampGBZ · Traditional | Applied Medical Resources | 03/03/1993SE |
| K924128 | Cholangiography CatheterGBZ · Traditional | Applied Medical Resources | 02/10/1993SE |
More from Applied Medical Resources
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|---|---|---|
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON…GDW · Traditional | 05/11/2026SE |
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)OXC · Traditional | 01/09/2026SE |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional | 12/17/2025SE |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional | 05/14/2025SE |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional | 02/25/2025SE |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional | 10/28/2024SE |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…GAG · Special | 07/03/2024SE |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special | 08/29/2023SE |
| K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue…GEI · Traditional | 04/13/2023SE |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional | 03/15/2023SE |
Questions and answers
When was Endopath cleared by the FDA?
Endopath (K942450) received a 510(k) decision of Substantially Equivalent on August 5, 1994, 74 days after the submission was received.
What is the product code of K942450?
The FDA product code is GBZ – Catheter, Cholangiography, a Class I (low risk) device regulated under 21 CFR 878.4200.